Two patients recently saw me within a two-week span asking for a prescription for Belviq (lorcaserin), a weight-loss drug. Both patients told me they had seen the drug advertised on television. Like most direct-to-consumer (DTC) ads, the one for Belviq ended with the advice to "ask your doctor about" it.
Based on my knowledge of weight loss drugs, my initial reaction was a negative one. The last weight-loss rage for phentermine+fenfluramine ("phen–fen") resulted in patients with damaged heart valves—an adverse effect that became evident only after millions of patients used the drug combination for many years. And with all the weight-loss drugs I have seen, the benefits in terms of weight loss were neither dramatic in magnitude nor long-lasting in duration.
That gut reaction notwithstanding, I recognized the patients' sincere desire to lose weight. Both were middle-aged women whose body-mass index (BMI) scores were above 30, thus putting them in the category of "obese." Belviq is approved by the Food and Drug Administration (FDA) for patients with a BMI of 30 or higher.
The first patient said she had been trying to lose weight on her own but had been unsuccessful. I thought this was a good opportunity for the patient and me to balance the pros and cons of taking the drug. I opened a recent issue of The Medical Letter that reviewed Belviq. Together, we read the indications for its use, how effective it was likely to be, and its side effects. After reading this information, I remained skeptical of her use of this drug, but she reiterated her fervent desire to try this drug as a means to lose weight. So I agreed to allow her to start the drug on a trial basis, so long as she agreed to stop taking it if was unable to lose 5 percent of her weight within three months. She agreed to that stipulation, which is included in the drug labeling.
A second patient of mine who asked for Belviq was struggling with weight loss, but she had already lost 5 pounds. I praised her successful efforts thus far with diet and exercise, noting that this was the best way to adopt a sustainable approach to weight control. When she reiterated her request for Belviq, I told her about the phen–fen disaster and the possibility that there could be hidden dangers with Belviq, as well. Though she still said she wanted the prescription, she agreed to continue on her own program of weight loss without drugs, with the understanding that we could revisit the question in a few months, depending on her continued progress.
These two cases highlight the controversy surrounding DTC advertising. Clearly, the TV ads for Belviq had motivated these patients to ask me for a prescription for the drug. In an ideal world, primary care providers would proactively engage their obese patients in discussions about weight loss without DTC advertising. Indeed, DTC advertising is not permitted by governments in the rest of the world other than in the United States and New Zealand. But here in the U.S. the FDA allows such advertising and physicians must be prepared to deal with DTC ad-driven patient demand.
Drug companies will do everything they can to maximize that demand and the sales that advertising promises. This can include promising consumers better outcomes, while downplaying the risks of taking a drug.
My patients were a perfect example of the outcome drug companies hope for, except for one thing. Both of my patients were covered by Medicaid, and in Connecticut where I practice, the state Medicaid program does not cover drugs for weight-loss, even though they cover other weight-loss treatments.
My patients were not the kind of patient that these DTC ads were intended to reach. The drug company wants to motivate patients with commercial insurance to go ask their doctors about Belviq. But commercial insurance companies should be just as careful as Medicaid in evaluating whether specific drugs with limited benefits should be covered. Our nation's ability to achieve sustainable, affordable health care for all depends on avoiding expensive treatments that are likely to be wasteful (because less expensive equally good alternatives are available),unnecessary or even counterproductive, because of risky side effects.
For the time being, DTC advertising appears to be here to stay in the U.S., but that doesn't preclude steps that can be taken to mitigate its most worrisome features.
First, all DTC ads should be approved by the FDA before they are released to the public. This will assure that an accurate presentation of the risks and benefits is achieved.
Second, DTC advertising should be prohibited for at least two years after a drug is first released. This can help limit the extent of its use during the critical period of time when unknown rare but serious and potentially lethal side effects may become evident.
Third, the revenue generated from financial penalties levied against companies for false and misleading advertising should be used for public service advertising and educational activities that warn patients about the risks of prescription drugs and promote healthier alternatives.
Finally, medical students, residents, and practicing physicians must learn skills in communication to more effectively interact with patients who, having just seen an ad on TV, come in and “ask their doctor about….”
Stephen R. Smith, M.D., M.P.H., Community Catalyst physician consultant